Kornimate/medical-research-clean huggingface dataset:
0.3% sodium hyaluronate in the treatment of dry eye of diabetic patients

Conditions: Dry Eye Syndromes; Diabetes Mellitus

Summary: a randomized parallel controlled study was designed to compare the efficacy of 0.3% sodium hyaluronate in the treatment of dry eye of diabetic patients.


Eligibility criteria:
inclusion criteria: 1. medical history of diabetes 2. diagnosed with proliferative diabetic retinopathy 3. diagnosed with dry eye 4. not involvement in other drug experiment in the past 2 weeks 5. vision acuity better than 0.1 6. no local drug using history or with at least 2 weeks blanking period exclusion criteria: 1. allergy to any of the drug ingredient 2. being or going to be pregnant or in lactation period 3. with any other eye disease or other serious disease which might affect the trial or could not get in follow-up 4. with any eye surgery history in the past six months 5. usage of hormone for replacement therapy

Keywords: dry eye syndromes diabetes mellitus
weight loss among adults in beijing, china

Conditions: Obesity; Hypertension

Summary: the purpose of this study is to test the effect of a mobile phone-assisted lifestyle intervention on weight loss at 6 months among overweight/obese chinese adults, as compared to a control group.

the rapid gains in china's economic development during the past two decades have been accompanied by similar gains in the population's waistline. over 25% of chinese adult females and more than a third of males are overweight or obese and rates are highest in urban areas such as beijing. by 2015, overweight/obesity prevalence in china may reach 50% , thus imposing a heavy toll on chronic disease rates and health care costs. despite these pressing public health challenges, very few obesity intervention studies have been conducted among chinese adults. duke university and peking university have partnered to implement an intervention to address these rapid changes in weight. 124 participants in beijing will be randomly assigned to either: (1) usual care (uc), or; (2) a 6-month weight loss (wl) intervention condition. the primary outcome is weight change (kg) at 6 months post-baseline. secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline. participants randomized to the intervention arm will receive a series of components, delivered over 6 months: personalized behavior change goals to be self-monitored via text messaging, group "starter" counseling sessions, and personalized individual counseling. each participant will also receive a pedometer to facilitate self-monitoring. these are evidence-based approaches, drawn from the investigators' collective research experience.

Eligibility criteria:
inclusion criteria: * bmi ≥ 24, * age 30-55 years * current use of a mobile phone * interest in losing weight. exclusion criteria: * pregnancy or plans to become pregnant within 10 months of recruitment * current lactation * occurrence of a major cardiovascular disease (e.g., myocardial infarction or stroke in the past 6 months) * other serious medical conditions that contraindicate weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment in past 2 years) * blood pressure ≥ 160/100 mm hg * type 2 diabetes or controlled by lifestyle only * use of medications known to increase body weight * substance abuse; psychiatric illness, including major depression, which could interfere with study adherence * prior or planned bariatric surgery * use of weight loss medications or weight loss ≥ 5% of initial weight in past 6 months * plans to relocate in next 10 months
sublingual misoprostol with or without intravenous tranexamic acid during hemorrhagic cesarean section

Conditions: Cesarean Section Complications

Summary: purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (ta) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (cs) -related hemorrhage; however, some studies reported that oxytocin use in the setting of cs may result in maternal adverse effects, including hypotension and tachycardia., therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. therefore, anti-fibrinolytic agents, such as tranexamic acid (ta), reduce the risk of death in bleeding trauma patients. on the other hand, it has been suggested that ta administration reduces blood loss and the incidence of postpartum hemorrhage (pph) in females after vaginal or elective cs verse effects and higher efficacy is needed. moreover, misoprostol is a prostaglandin e1 analog which has been introduced as a uterotonic agent for preventing pph following cs. a recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe pph, following cs

Eligibility criteria:
inclusion criteria: * women who undergone elective cesarean section (c.s) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus * age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, cs with inferior segment incision, and spinal anesthesia. exclusion criteria: * having an underlying disease (heart, liver, kidney, pulmonary, etc.), * eclampsia and severe preeclampsia * allergy to ta (such as known allergy or thromboembolic event during pregnancy) and misoprostol * coagulation disorders * refuse or unable to consent

Keywords: cesarean section tranexamic acid misoprostol
a pilot study of curcumin and ginkgo for treating alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing alzheimer's disease (ad) progression.

a double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing alzheimer's disease (ad) progression. curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. because of its strong anti-inflammatory activity, curcumin was tested in animal models of ad, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. ad patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. all patients will also receive 120 mg ginkgo leaf extract daily. at 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. curcumin and its metabolites will be measured in blood at 1 month. the primary objective for this first human study of curcumin in ad is to examine safety and procedures for a possible larger trial testing curcumin against ad. the secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. the tertiary objective is to determine whether curcumin slows cognitive decline in ad. this study may lead to inexpensive treatment that delays progression of ad.

Eligibility criteria:
inclusion criteria: * ethnic chinese living in hong kong * progressive decline in memory and cognitive function for at least 6 months * nincds-adrda diagnosis of possible or probable ad * mild to severe dementia with cantonese version of mmse scores between 0 and 28 * informed consent from patient and/or caregiver * both elderly home residents and outpatients are eligible * patients may take any medication exclusion criteria: * anticoagulant or antiplatelet treatment or bleeding risk factors * currently smoking * other severe, end-stage illness

Keywords: dementia cognition memory neurodegenerative disease brain
influence of the use of the diabetic drug metformin on the overall survival and treatment-related toxicity in advanced stage non-small cell lung cancer patients.

Conditions: Non Small Cell Lung Cancer

Summary: there are preliminary data suggesting that patients suffering from non-insulin-dependent diabetes mellitus, treated with metformin, have improved local tumor control. a reduction in the tumor's hypoxia may be responsible for this phenomenon. therefore, the aim of this study is to test the hypothesis in three cohorts of patients suffering from advanced stage non-small cell lung cancer and all undergoing concurrent radiochemotherapy: 1. patients with diabetes mellitus treated with metformin only; 2. patients with insulin-dependent diabetes mellitus not treated with metformin; 3. the remaining patients serving as controls. furthermore, tumor and treatment-related parameters will be correlated with overall survival and morbidity.

there are preliminary clinical and preclinical data suggesting that patients suffering from non-insulin-dependent diabetes mellitus, treated with metformin, have improved local tumor control. the reduction in oxygen consumption of tumor cells and thus a relative reduction in the tumor's hypoxia may be responsible for this. non-small cell lung cancer is the most frequent solid tumor in many western countries and the number one cause of cancer-related death. even though the introduction of concurrent chemoradiotherapy has improved local tumor control and thus overall survival, 5-year overall survival is still as low as 14%. furthermore, many patients are not eligible to undergo concurrent treatment thus reducing their chances to defeat this disease. additionally, concurrent chemoradiotherapy is associated with increased toxicity compared to sequential treatment. therefore, alternative additives improving the effect of radiotherapy without increasing toxicity to an unbearable level are searched for. one possible pharmaceutical is metformin; many patients have been using it in the past without evident increased toxicity, it is cheap, and widely available. thus, the aim of this study is to test the hypothesis that metformin increases overall survival without enhancing treatment-related toxicity. for this means, in three cohorts of patients suffering from advanced stage non-small cell lung cancer and all undergoing concurrent radiochemotherapy: 1. patients with diabetes mellitus treated with metformin only; 2. patients with insulin-dependent diabetes mellitus not treated with metformin; 3. the remaining patients serving as controls. using kaplan-meier statistics as well as uni- and multivariate analysis, the overall survival and toxicity of these cohorts will be compared. other potentially confounding factors will be tested as secondary endpoints.

Eligibility criteria:
inclusion criteria: advanced non-small cell lung cancer patients undergoing primary concurrent radiochemotherapy; patients treated with metformin or insulin will be analyzed as separate cohorts.
research and application of ultrasonic intelligent diagnosis system for ovarian mass

Conditions: Ovarian Neoplasms; Adnexal Mass

Summary: research on automatic detection of ovarian mass and intelligent auxiliary diagnosis system based on multimodal ultrasound images.

investigators aimed to develop an ultrasonic intelligent diagnosis system for ovarian mass based on multimodal ultrasound images.

Eligibility criteria:
inclusion criteria: 1. during gynecological ultrasound examination, at least one patient with persistent ovarian tumor was found. 2. the patient underwent surgical treatment and the histopathological results. exclusion criteria: 1. histopathological analysis confirms non-ovarian tumor; 2. histopathological results are inconclusive; 3. issues with image quality: the ovarian mass is incomplete and does not show some surrounding tissues (but the mass is too large to exclude completely); the images are overly blurry, making it difficult to determine the characteristics of the ovarian mass (possible reasons include hardware quality issues with the ultrasound machine, motion blur, focusing problems, presence of intestinal gas in the patient); gain settings make it difficult to judge the characteristics of the ovarian mass (such as low contrast, excessively dark images, or saturation); the presence of artifacts affects the assessment of ultrasound characteristics of the ovarian mass and should be excluded.
safety and efficacy of devices used in fetoscopic neural tube defect repair cases

Conditions: Neural Tube Defects

Summary: the purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

all patients who choose to undergo fetoscopic neural tube defect repair at texas children's fetal center will be offered participation in this research study by study investigators. description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. once the patient is deemed eligible the informed consent process will be reviewed. if patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent. fetoscopic procedure: the fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this ide (nct02230072 and nct03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. this involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. if necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. if the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject. follow-up: the investigators will follow patients for the immediate post-procedure period (until they leave the or).

Eligibility criteria:
inclusion criteria: * patients who elect to undergo fetoscopic neural tube defect repair exclusion criteria: * patients who do not elect to undergo fetoscopic neural tube defect repair

Keywords: myelomeningocele mmc ntd neural tube defect spina bifida
efficacy and safety of kochujang pills on improvement of blood lipids

Conditions: Hyperlipidemia

Summary: the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of kochujang pills on improvement of blood lipids. the investigators measured improvement of blood lipids parameters , including total cholesterol, ldl-c, triglyceride and hdl-c, and monitored their blood pressure.


Eligibility criteria:
inclusion criteria: * males and females 19-55 years old * total cholesterol 200\~260 mg/dl or ldl-c 110\~190 mg/dl * able to give informed consent exclusion criteria: * allergic or hypersensitive to any of the ingredients in the test products * history of reaction to any of the test products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnant or lactating women etc.
sensitive periods in human flavor learning

Conditions: Development

Summary: the goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. the investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.

this is a randomized clinical trial on both breastfeeding and formula feeding infants to determine the effects of the timing of flavor experiences on subsequent food acceptance in both members of the dyad.

Eligibility criteria:
inclusion criteria: * healthy, term infants and their mothers * infants 2 wks (+/- 2 wk of age) * mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula * mothers must be older than 18 years of age exclusion criteria: * infants who were preterm or have medical conditions that interfere with feeding or eating * mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery * mothers who will be going back to work full-time before the infant is 4 months old * mothers who are allergic to any vegetables * subjects will not be excluded because of economic status, gender, race or ethnicity.

Keywords: breastfeeding flavor learning mother moms infants babies baby food habits fruits vegetables
a study utilising data from european union (eu) national multiple sclerosis (ms) registries to assess the incidence of anti-natalizumab antibody among participants who receive subcutaneous administration of natalizumab for treatment of relapsing-remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis

Summary: the primary objective of this study is to estimate the incidence of anti-natalizumab antibodies (anas) in the cohort of natalizumab-naïve and other ms monoclonal antibody (mab)-naive participants who start receiving natalizumab subcutaneous (sc) injections. the secondary objectives of this study are to estimate the proportion of participants detected with anas when switched from natalizumab intravenous (iv) to natalizumab sc (natalizumab-experienced cohort); to evaluate serious adverse events (saes), including injection reactions and hypersensitivity reactions, by ana status and to assess the proportion of participants who had ms relapse, by ana status.

the study will collect data prospectively and retrospectively.

Eligibility criteria:
key inclusion criteria: * participants who are natalizumab-naïve and other ms mab-naive and who start on natalizumab sc. * participants who have previously received natalizumab iv and switch from natalizumab iv to sc administration. key exclusion criteria : * for the natalizumab-naive and other ms mab-naive cohort, participants who previously received natalizumab or other ms mabs will be excluded. * for the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded. note: other protocol defined inclusion/exclusion criteria may apply.
pro-inflammatory cytokines in blood from orthopedic surgery compared to abdominal aneurysm repair

Conditions: Aortic Diseases; Osteoarthritis, Hip

Summary: the purpose of this study is to investigate the contents in blood sampled from surgery site during hip replacement compared with blood sampled from abdominal aortic surgery. is there any difference in pro-inflammatory cytokines (il-1beta, il-6, il-8 and tnf-α), complement activation (c3a)?

patient (n= 10) scheduled for total hip replacement or hemiprosthesis and patient (n=10) scheduled for abdominal aortic surgery. primary outcome: pro-inflammatory cytokines (il-6, il-8 and tnf-α) and complement activation (c3a) in blood samples collected from surgery field. comparison between the 2 groups. secondary outcome: haemoglobin, trc, inr in blood samples and plasma will be analysed and compared between the 2 groups.

Eligibility criteria:
inclusion criteria: * asa 1-4 exclusion criteria: * patient using corticosteroids, nsaids or cox-ii inhibitors * patients under 18 years * patients who are included in pharmaceutical studies * opioids-, benzodiazepines-, antiepileptic drugs-, alcohol- and α2-agonists abuse * pregnant and breastfeeding women * patients with known hypersensitivity for opioids, propofol or volatile anesthetics * patients with serious arrhythmias (atrial fibrillation/flutter is acceptable) * uncontrolled hypertension, serious psychiatric disease * patients with unstable angina pectoris or myocardial infarction the last month before inclusion * acute abdominal aortic surgery (acute dissection or rupture) * planned laparoscopic abdominal aortic aneurysm surgery * transfusion of blood products last month before surgery * glucocorticoid users

Keywords: aorta disease abdominal surgery osteoarthritis, hip replacement blood autolog transfusion cytokines
individualized data-based high simulation of bronchoscopy operations in preoperative bronchoscopy informed consent

Conditions: Bronchoscopy

Summary: a prospective randomized controlled study was conducted to investigate whether preoperative replacement of patients based on ai training instruments could alleviate preoperative anxiety. patients who met the criteria were randomly assigned to either the personalized data-based group or the control group. prior to the preoperative account examination, each patient's anxiety level was assessed, after which a 30-40-minute informed consent form was read. the traditional group underwent a preoperative account and question-and-answer session with an experienced bronchoscopy laboratory physician, after which the scale was reassessed. the experimental group underwent a simulated surgical procedure on an ai simulation instrument based on the patient's ct personalized data, performed by an experienced bronchoscopist. the bronchoscopist explained the surgical precautions and answered the patient's questions throughout the procedure. following the responses to the questions, the scale was reassessed. following surgery, patients are invited to complete a satisfaction survey prior to discharge or following the discussion of bronchoscopy findings.


Eligibility criteria:
inclusion criteria: * requiring elective bronchoscopy * older than 18 years exclusion criteria: · dementia, limited speech, or other problems affecting communication

Keywords: communication informed consent physician-patient relations ai bronchoscopy
influence of pneumonia on delayed cerebral ischemia after subarachnoid hemorrhage . sah-cip (subarrachnoid hemorrhage - cerebral infarction pneumonia)

Conditions: Subarachnoid Hemorrhage; Pneumonia, Bacterial

Summary: prognosis of subarachnoid hemorrhage (sah) is scarce, indeed almost half patients die or become severely disable after sah. outcome is related to the severity of the initial bleeding and delayed cerebral infarction (dci). infection and more precisely pneumonia have been associated with poor outcome in sah. however, the interaction between the two pathologic events remains unclear. therefore, we hypothesized that dci may be associated to pneumonia in sah patients. thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with sah. retrospective, observational, monocentric cohort study, including patient admitted in neurosurgical intensive care unit or surgical intensive care unit in the university hospital of brest (france) for non-traumatic sah. primary outcome is diagnosis of dci on ct scan or mri 3 months after sah. multivariate analysis is used to identify factors independently associated with dci. we plan to include between 200 and 250 patients in the analysis.


Eligibility criteria:
inclusion criteria: * admitted in icu in brest university hospital * for non traumatic subarachnoid hemorrhage * between july 2015 and december 2018 exclusion criteria: * continuation of care out of brest university hospital after initial icu stay * refusal to participate

Keywords: subarachnoid hemorrhage pneumonia delayed cerebral ischemia vasospasm delayed cerebral infarction